Kornimate/medical-research-clean huggingface dataset:
galantamine bioequivalence study of dr. reddy's under fed condition

Conditions: Fed

Summary: galantamine hydrobromide tablets, bioequivalence study of dr. reddy's under fed condition.

comparative, randomized, single-dose, 2-way crossover bioavailability study of dr.reddy's laboratories, ltd. and janssen pharmaceutical products, l.p. (reminyl®)4 mg galantamine hbr tablets in healthy adult male volunteers under fed conditions

Eligibility criteria:
inclusion criteria: subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the studyi unless otherwise specified: * healthy adult male volunteers, 18-55 years of age; * weighing at least 60 kg and within 15% of their ideal weights (table of "desirable weights of adults", metropolitan ufe insurance company, 1983); * medically healthy subjects with clinically normal laboratory profiles, vital signs and ecgs; * give voluntary written informed consent to participate in the study. exclusion criteria: subject candidates must not be enrolled in the study if they meet any of the following criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. * in addition, history or presence of: * alcoholism or drug abuse within the past year; * hypersensitivity or idiosyncratic reaction to galantamine or other anticholinesterase inhibitors; * asthma and seizures. * subjects who tested positive at screening for hiv, hbsag or hcv. * subjects whose pr interval is \>200 msec at screening and prior to dosing. * subjects whose qtc interval is \>450 msec at screening and prior to dosing. * subjects who have used any drugs or substances known to be strong inhibitors of cyp enzymes (formerly known as cytochrome p450 enzymes) within 28 days prior to the first dose. * subjects who have used any drugs or substances known to be strong inducers of cyp enzymes (formerly known as cytochrome p450 enzymes) within 28 days prior to the first dose. * subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study. * subjects who, through completion of the study, would have donated in excess of: 500 ml of blood in 14 days; 1500 ml of blood in 180 days; 2500 ml of blood in 1 year. * subjects who have participated in another clinical trial within 28 days prior to the first dose.
a mobile-app training to reduce body image disorder symptoms and associated features in female university students

Conditions: Body Image Disorder; Body Dysmorphic Disorders; Eating Disorders

Summary: body dissatisfaction represents a prevalent condition in young women, and it is associated with low self-esteem, depression, and symptoms of body dysmorphic disorder (bdd) and eating disorders (eds). the aim of the trial is to test the effect of a mobile health application called "ggbi: positive body image" in reducing body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features in female university students considered at high-risk of developing body image disorders (bids). hypothesis: participants using "ggbi: positive body image" immediately following baseline assessment (time 0; t0) (immediate-use app group: iapp) would exhibit greater reduction in body dissatisfaction, body dysmorphic disorder/eating disorder symptoms, and associated psychological features than participants who did not use "ggbi: positive body image" in this phase of the study (delayed-use app group: dapp). following crossover (time 1; t1), the investigators expect that participants gains in the iapp group would be maintained at follow-up (time 2; t2).


Eligibility criteria:
inclusion criteria: * presence of body image disorder symptoms exclusion criteria: * presence of a full-blown body image disorder * presence of a psychotic/schizophrenic disorder * current treatment for a body image disorder
role of platelet rich plasma in bone regeneration after enucleation of odontogenic jaw cysts

Conditions: PRP & Jaw Cysts

Summary: in the present study, the effect of prp on bone regeneration when applied to the site of removal of cyst of the jaws is evaluated. prp was delivered to the site combined with gelfoam. thrombin clot accelerator was not used.

jaw cysts are common lesions in the oral and maxillofacial region. enucleation of cyst wall \& curettage has evolved as the treatment of choice. in order to reduce infections and to accelerate bone regeneration, by using of platelet rich plasma. platelets are involved in regeneration at sites of pathology, apart from their role in clotting. a preparation composed mainly of platelets (platelet-rich plasma gel) applied to sites of bony pathology, after surgical treatment of lesions, may hasten bone regeneration. an interesting idea developed that the addition of a concentrate of platelets, to wounded tissues or surgical sites, may enhance the body's natural wound healing mechanisms . platelet-rich plasma (prp) is the accepted term to describe the preparation made out of autologous platelets suspended in autologous plasma, in concentration greater than normally found in peripheral blood because it is autologous, prp avoids the risk of transmissible diseases such as hiv, hepatitis b, c or d and other blood-borne pathogens .a clot accelerator such as bovine thrombin is added to gel the prp or prp is added to other materials such as collagen, gelfoam, etc.

Eligibility criteria:
inclusion criteria: 1. size of the cyst more than 2 cm 2. the lesion could be visualized radiographically 3. patients within the age range of 20 to 50 years exclusion criteria: 1. patients who were alcoholics \& smokers 2. -patients with systemic diseases 3. history of bleeding tendencies, blood dyscrasia 4. low platelet count 5. patients unable or unwilling to return for follow-up
a safety and efficacy study of onabotulinumtoxina in premature ejaculation

Conditions: Premature Ejaculation

Summary: this is a safety and efficacy study of onabotulinumtoxina for the treatment of premature ejaculation (pe) in male participants.

this is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-escalation study to assess a range of doses of onabotulinumtoxina for the treatment of male participants with pe. participants will attend a minimum of 6 or 7 clinic visits and also have 1 or 2 telephone visits. partners will need to attend a clinic visit during the screening period to provide informed consent and to receive training on measurement and recording of the intravaginal ejaculatory latency time (ielt). participants will be enrolled in cohorts. within the first 5 cohorts, 8 participants are to receive onabotulinumtoxina and 2 participants to receive placebo. for cohort 6, 12 participants will receive onabotulinumtoxina and 12 participants will receive placebo. participants will receive a single treatment of study medication delivered bilaterally to the bulbospongiosus muscle. the initial onabotulinumtoxina total dose in this dose escalation study will be 5 u and the maximum onabotulinumtoxina total dose will be 100 u. upon request and if eligible, participants in cohort 6, will have the option to receive a second injection of onabotulinumtoxina (open-label).

Eligibility criteria:
inclusion criteria: * history of premature ejaculation * stable monogamous sexual relationship with female partner for at least 6 months, and intends to continue with the same partner for the duration of the study * participant has ability to follow study instructions and complete study assessment tools exclusion criteria: * premature ejaculation caused by medical or surgical issues, or is related to stress or other issues (eg, relationship problems) * pain with ejaculation * planned use of topical penile treatments (eg, anesthetics, herbal treatments) or penile injections during the study * prior genital, prostatic or lower urinary tract surgery (other than vasectomy or circumcision) * previous or current usage of botulinum toxin therapy of any serotype for any urological condition * use of botulinum toxin therapy of any serotype for any nonurological condition (eg, cosmetic, chronic migraine) during the 12 weeks prior to screening, or planned usage during the study * diagnosis of myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis
effect of anti-inflammatory diet on inflammatory, oxidative and nutritional markers in hemodialysis patients

Conditions: Inflammation; Malnutrition; Protein Energy Wasting Syndrome; Oxidative Stress; Diet Therapy

Summary: the purpose of this study is to evaluate the effect of especial diet therapy "anti-inflammatory diet" on inflammatory, oxidative stress, and nutritional markers in the context of protein-energy wasting syndrome(pew) in hemodialysis patients.


Eligibility criteria:
inclusion criteria: * patients who are on hemodialysis(hd) at least two times a week for 3months or more without any internment illness or admission exclusion criteria: * hospitalization because of sepsis or surgery 3 months prior to intervention * cirrhosis * hepatitis virus infection * human immunodeficiency virus infection * acquired immunodeficiency syndrome * active malignancy * active infection * absence of communication * mental impairment * terminal illness * tube feedings * total parenteral nutrition * pregnancy * not previously seen by a dietitian within 3 months prior to enrollment in the study * not expected to be transplanted within 6 months after the enrollment in the study * absence of malnutrition from a cause other than end stage renal disease(esrd) * psychiatric conditions, preventing adherence to intervention * consuming immunosuppressive drugs or taking antioxidant supplements including vitamin e, vitamin c, n-acetyl- cysteine (nac), pentoxifylline, lipoic acid,fish-oil extracts (omega-3 fatty acids), soy extracts(isoflavones), green-tea preparations, pomegranate extracts, grape extracts within 2 months prior to enrollment in the study

Keywords: hemodialysis diet inflammation malnutrition
health related quality of life in lung transplantation in strasbourg

Conditions: Lung Transplantation

Summary: the aim of this study is to study the quality of life in lung transplant patients. the cohort includes all of the surviving and transplanted patients at the new civil hospital in strasbourg between 2008 and 2018. the main objective is to assess the quality of life of this cohort by two questionnaires which are the sf36 (generic score) and the saint georges's questionnaire (specific score). the secondary objectives are the measurement of survival after lung transplantation, the comparison of the quality of life of these patients with that of the general population by the sf36 questionnaire, the search for perioperative factors influencing the quality of life and finally the search for an association between quality of life and socio-professional life.


Eligibility criteria:
inclusion criteria: * transplants survivors in strasbourg hospital between 2008 et 2018 * patient able to answer a questionnaire in french exclusion criteria: * pregnancy * vulnerability * safeguard of justice, curatorship or tutorship * emergency situation * difficilty in understanding

Keywords: health related quality of life lung transplantation sf36 st georges's respiratory
study to compare efficacy and safety of ct-p42 in comparison with eylea in patients with diabetic macular edema

Conditions: Diabetic Macular Edema (DME)

Summary: this is a randomized, active-controlled, double-masked, parallel-group, phase 3 study to compare efficacy and safety of ct-p42 in comparison with eylea in patients with diabetic macular edema


Eligibility criteria:
inclusion criteria: * male or female patient aged ≥18 years. * patient with dme secondary to dm involving the center of the macula (defined as the optical coherence tomography \[oct\] central subfield) in the study eye. exclusion criteria: * patient who has only one functional eye. * patient who currently has, or has a history (where indicated) of active proliferative diabetic retinopathy
the association between uterine artery notch and first trimester bleeding

Conditions: Uterine Artery Notch; First Trimester Bleeding

Summary: the purpose of the present study is to evaluate the occurrence of first trimester bleeding among patients with abnormal uterine artery doppler. a prospective study is designed and two groups will be studied; patients with abnormal uterine artery doppler at second trimester (study group) and patient with normal uterine artery doppler at second trimester (control group).the patients will be asked, as part of the routine history taken before the us about having first trimester bleeding during the current pregnancy.

the purpose of the present study is to evaluate the occurrence of first trimester bleeding among patients with abnormal uterine artery doppler. a prospective study is designed and two groups will be studied; patients with abnormal uterine artery doppler at second trimester (study group) and patient with normal uterine artery doppler at second trimester (control group). both the study group and the control group represent high risk pregnant patients and the doppler flows are done as part of the patient's predictive risk for placental associated abnormalities. the patients will be asked, as part of the routine history taken before the us about having first trimester bleeding during the current pregnancy.

Eligibility criteria:
inclusion criteria: * patients with abnormal uterine artery doppler at second trimester exclusion criteria: * multi fetal pregnancies * patients without known gestational age (according to last month period or first trimester ultrasound * pregnancies with congenital structural or chromosomal anomalies * lack of prenatal care

Keywords: notch uterine first bleeding
the effect of the sns-based feeding on transition to exclusive breastfeeding in preterm infants

Conditions: Breastfeeding; Preterm Infant; Sucking Behavior

Summary: this study investigated the effect of the supplemental nursing system (sns)-based feeding on the time to transition to exclusive breastfeeding, sucking success, and the time to discharge in preterm infants

nutrition is a critical problem in preterm infants. they should initially be enterally fed because they have poor sucking-swallowing-breathing coordination. once a preterm infant develops that coordination, enteral feeding should be discontinued immediately. then, the preterm should switch to oral feeding (breastmilk). however, preterm infants are not good at sucking because they get tired too quickly, have poor sucking skills, and lack enough experience. therefore, we must use alternative supplemental feeding methods (bottle, spoon, dropper, cup, breastfeeding support system, and finger feeding) until preterm infants mature enough to meet their daily nutritional needs by breastfeeding alone (exclusive breastfeeding). the supplemental nursing system (sns) is an alternative supplemental feeding method that supports the development of sucking skills while providing the preterm infant's nutritional needs. this study investigated the effect of the supplemental nursing system (sns)-based feeding on the time to transition to exclusive breastfeeding, sucking success, and the time to discharge in preterm infants.

Eligibility criteria:
inclusion criteria: * being between the gestational ages of 30 to 34 weeks * having a birthweight of ≥1000 g * having an apgar score of \>6 * having stabilized for 48 hours after receiving mechanical ventilator or continuous positive air pressure or both * being exclusively gavage-fed with breast and/or formula and ready to switch to oral feeding * being willing to breastfeed exclusion criteria: * having a congenital malformation that may cause asphyxia and affect breathing * having an intraventricular hemorrhage, intracranial hemorrhage, or periventricular leukomalacia * having intestinal anomalies or hyperbilirubinemia requiring exchange transfusion * having respiratory distress syndrome, bronchopulmonary dysplasia, or other chronic lung diseases.
xenon in off-pump coronary artery bypass graft surgery

Conditions: Coronary Artery Disease; Anesthesia

Summary: purpose of this study is to test whether xenon application during off-pump-coronary artery bypass (opcab)-surgery is safe and feasible.

the investigators hypothesize that xenon application during opcab-surgery performs non-inferiorly to the administration of the established anaesthetic sevoflurane with regard to haemodynamic stability, respiratory function, and depth of anesthesia. the evaluation of the outcome will include several secondary parameters such as the incidence of post-operative cardiovascular and neurovascular events, the incidence of organ dysfunction and further adverse events. this study will further function as a pilot study for the evaluation of the incidence of postoperative delirium (pod) following opcab-surgery and xenon treatment. pod is a common complication of cardiac surgery/anaesthesia and may significantly affect the patients' mortality and outcome. xenon possesses neuroprotective and anti-inflammatory qualities that may directly interfere with the pathogenesis of pod, as well as reducing other factors of perioperative organ injury including cardiac complications. xenon´s favourable pharmacokinetic properties further result in rapid clearance from the brain, reducing any residual anaesthetic effects that may predispose to pod.

Eligibility criteria:
inclusion criteria: * patients with coronary artery disease scheduled for elective opcab- surgery * patients willing and able to complete the requirements of this study * ejection fraction \> 30% exclusion criteria: * lack of informed consent * age \< 18 years * pregnancy * chronic obstructive pulmonary disease (copd) gold \> ii * renal dysfunction defined as serum-creatinine \> 1.5 mg/dl * acute coronary syndrome during the last 24 hours; haemodynamic instability, requirement of inotropic support * single vessel grafting * disabling neuropsychiatric disorders (severe dementia, alzheimer's disease, schizophrenia, depression), history of stroke with residuals, significant stenosis of carotid arteries, increased intracranial pressure * hypersensitivity to the study medication * presumed uncooperativeness or legal incapacity

Keywords: xenon anesthesia sevoflurane anesthesia off-pump coronary artery bypass graft surgery
a multicenter，double-blind and randomized controlled trial of fengshigutong capsule in the treatment of ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this is a randomized, double-blind, multicentral clinical trial to investigate the efficacy and safety of fengshigutong capsule in the treatment of active ankylosing spondylitis(as). the primary purpose is to assess the different maintaining treatment programme in as patients with controlled inflammation by imrecoxib. the trial will include 180 patients who will be divided into three group: fengshigutong capsule plus imrecoxib group, imrecoxib group and fengshigutong capsule group. patients will complete the 4-week therapy.


Eligibility criteria:
inclusion criteria: * 18 to 65 years * meet 1984 modified new york criteria for as * the bath as disease activity index (basdai) ≥4 on a 0-10-cm visual analog scale or the ankylosing spondylitis disease activity score using the c-reactive protein level (asdas-crp) ≥1.3 * nsaids washout period of at least 7 days prior to randomization * dmards washout period of at least 4 weeks prior to randomization * corticosteroids washout period of at least 2 weeks prior to randomization * biological agents washout period of at least 3 months prior to randomization. exclusion criteria: * peptic ulcer * unstable cardiac diseases * hematologic disorders * psychosis * malignancy * multiple sclerosis * severe copd * fibromyalgia and other rheumatic disease * corticosteroids were injected into the articular cavity within 3 months * chinese medicine was taken within 28 days * pregnant and lactating women * alcohol and drug abuse * spinal cord compression

Keywords: ankylosing spondylitis fengshigutong capsule imrecoxib
ulcerative colitis study: study of visilizumab in patients with severe ulcerative colitis

Conditions: Severe Ulcerative Colitis

Summary: the purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy. what is visilizumab? visilizumab is an antibody designed to reduce inflammation. antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances. visilizumab is thought to selectively affect the immune system to decrease inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative colitis. who can participate in this study? the target population for this study is adults with severe ulcerative colitis that has resisted intravenous (iv) steroids. this study is open to patients with the following characteristics: * 16-70 year olds * a diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry * active disease despite ongoing treatment with steroids how is this study conducted? eligible participants will be administered visilizumab as one daily injection on two consecutive days. all medication and study-related care, except for the costs of in-patient hospitalization, are provided to qualified participants at no cost. this includes all visits, examinations and laboratory work. how does one get more information? this study is currently enrolling patients at hospitals and clinics in north america and europe. for more information on the study or how to participate in it, please call 1-800-772-0482, email infocenter@pdl.com or visit www.ibdtrials.com.

pdl biopharma, inc. was formerly known as protein design labs, inc.

Eligibility criteria:
inclusion criteria: * 16 -70 year olds * a diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry * active disease despite ongoing treatment with iv steroids
determination of the optimal nutrient mix to acutely increase plasma ketones

Conditions: Overweight and Obesity

Summary: this study will be performed to determine the optimal nutrient mix (predominantly based on medium-chain triglycerides (mcts)) to induce a mild ketogenic state in healthy older (60-80y), overweight/obese (bmi: 25-35 kg/m2) individuals. since the aim is to induce a mild ketogenic state, a 25g mct-based nutrient mix, a 25g mct-based nutrient mix + cofactors, or a non-ketogenic control will be compared.


Eligibility criteria:
inclusion criteria: * aged 60-80 years * body mass index (bmi) 25-35 kg/m2 * stable dietary habits (no weight loss or gain \> 5 kg in the past 3 months) * participants are able to provide signed and dated written informed consent prior to any study specific procedures exclusion criteria: * type 2 diabetes * pre-diabetes based on one or a combination of the following criteria: * impairedfastingglucose(ifg):fasting plasma glucose ≥ 6.1mmol/l and ≤ 6.9 mmol/l. * hba1c of 5.7-6.4%. * participants with active congestive heart failure and/or severe renal and or liver insufficiency * uncontrolled hypertension * alcohol consumption of \> 3 servings per day for man and \> 2 servings per day for woman * unstable body weight (weight gain or loss \> 5 kg in the last 3 months) * previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results * significant food allergies/intolerance (seriously hampering study meals) * participants who do not want to be informed about unexpected medical findings * blood donation during or within 2 months prior to the study